Phase IV Study of Tarceva in Patients With Advanced Stage IIIB/ IV Non-small Cell Lung Cancer (NSCLC)

An Observational Study for Safety and Efficacy of Erlotinib Beyond 1st Line in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

Detailed Description

An observational non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients after chemotherapy.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 27
    • Oncology Unit Sotiria Hospital of Chest Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced (inoperable stage IIIB or stage IV) NSCLC who had failed in platinum based chemotherapy

Description

Inclusion Criteria:

• Histological or cytological documented diagnosis diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) NSCLC.
• Patients must have evidence of disease but measurable disease is not mandatory.
• 18 years of age or older.
• ECOG Performance Status of 0-2.
• Life expectancy at least 12 weeks.
• Patients with advanced stage IIIB/ IV NSCLC who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator's opinion not medically suitable for chemotherapy or radiotherapy.
• No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy.
• Granulocyte count ≥ 1.5 x 109/L and platelet count > 100 x 109/L.
• Serum bilirubin must be ≤ 1.5 upper limit of normal (ULN).
• AST and/or ALT ≤ 2 x ULN (or ≤ 5 x ULN if clearly attributable to liver metastasis.
• Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min.
• Able to comply with study and follow-up procedures.
• For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
• Patients with reproductive potential must use effective contraception.
• Written (signed) Informed Consent to participate in the study.

Exclusion Criteria:

• Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
• Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
• Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
• Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/ or has not yet been definitively treated with surgery and/ or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
• Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and the ophthalmologist.
• Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
• Nursing mothers.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Defined as the time period from the entry to the study until assessed disease progression or death	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse events and serious adverse events	Baseline, 4-6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure	Time Frame
Response Rate	4-6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Study Chair: KOSTAS N SYRIGOS, MD, PhD, Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: TKIs; Inoperable NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ML27805